| Trial ID: | L0352 |
| Source ID: | NCT02808312
|
| Associated Drug: |
Cilofexor
|
| Title: |
Pharmacokinetics and Pharmacodynamics of Cilofexor in Adults With Normal and Impaired Hepatic Function
|
| Acronym: |
--
|
| Status: |
Completed
|
| Study Results: |
Has Results
|
| Results: |
https://ClinicalTrials.gov/show/NCT02808312/results
|
| Conditions: |
Nonalcoholic Steatohepatitis (NASH)|Primary Sclerosing Cholangitis (PSC)
|
| Interventions: |
Drug: Cilofexor
|
| Outcome Measures: |
Pharmacokinetic (PK) Parameter: AUClast of Cilofexor|PK Parameter: AUCinf of Cilofexor|PK Parameter: Cmax of Cilofexor|PK Parameter: %AUCexp of Cilofexor|PK Parameter: Clast of Cilofexor|PK Parameter: Tmax of Cilofexor|PK Parameter: Tlast of Cilofexor|PK Parameter: ??z of Cilofexor|PK Parameter: CL/F of Cilofexor|PK Parameter: Vz/F of Cilofexor|PK Parameter: t1/2 of Cilofexor|Percentage of Participants Experiencing Treatment-Emergent Adverse Events|Percentage of Participants Who Experienced Graded Laboratory Abnormalities|Pharmacodynamic (PD) Parameter: Mean Day 1/ Day -1 Ratio of AUC2-12 for ??-hydroxy-4-cholesten-3-one (C4)|PD Parameter: Mean Day 1/ Day -1 Ratio of Cmin for ??-hydroxy-4-cholesten-3-one (C4)|PD Parameter: Mean Day 1/ Day -1 Ratio of AUC2-12 for Fibroblast Growth Factor 19 (FGF19)|PD Parameter: Mean Day 1/ Day -1 Ratio of Cmax for Fibroblast Growth Factor 19 (FGF19)
|
| Sponsor/Collaborators: |
Gilead Sciences
|
| Gender: |
All
|
| Age: |
18 Years and older ?? (Adult, Older Adult)
|
| Phases: |
Phase 1
|
| Enrollment: |
57
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: None (Open Label)|Primary Purpose: Treatment
|
| Start Date: |
July 13, 2016
|
| Completion Date: |
October 16, 2018
|
| Results First Posted: |
September 30, 2020
|
| Last Update Posted: |
January 7, 2021
|
| Locations: |
Miami, Florida, United States|Orlando, Florida, United States|Knoxville, Tennessee, United States|San Antonio, Texas, United States|Auckland, New Zealand
|
| URL: |
https://ClinicalTrials.gov/show/NCT02808312
|
